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Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket Nos. FDA2021D0242, FDA
2021D0243, FDA2021D0244, and FDA
2021D0245

Compliance Policy Guide Sec. 555.400
Aflatoxins in Human Food; Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil Nuts; Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut Products; and Compliance Policy Guide Sec. 570.500 Aflatoxins in Pistachio Nuts; Availability AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice of availability.

The Food and Drug Administration FDA or we is announcing the availability of four final Compliance Policy Guides CPG
entitled Compliance Policy Guide Sec.
555.400 Aflatoxins in Human Food, Compliance Policy Guide Sec. 570.200
Aflatoxins in Brazil Nuts, Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut Products, and Compliance Policy Guide Sec. 570.500
Aflatoxins in Pistachio Nuts. These CPGs revise the existing CPGs by updating the format and including references to other aflatoxins CPGs and a reference to the Memorandum of Understanding between the Agricultural Marketing Service AMS of the U.S.
Department of Agriculture USDA and FDA. The CPGs provide guidance for FDA staff on FDAs current regulatory criteria for aflatoxins in human food, Brazil nuts, peanuts and peanut products, and pistachio nuts.
DATES: The announcement of the guidances is published in the Federal Register on June 1, 2021.
ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows:

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SUMMARY:

Electronic Submissions Submit electronic comments in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting comments.
Comments submitted electronically, including attachments, to https
www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or
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anyone elses Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https www.regulations.gov.
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed see Written/Paper Submissions and Instructions.
Written/Paper Submissions Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions.
Instructions: All submissions received must include Docket No. FDA2021D
0242 for Compliance Policy Guide Sec.
555.400 Aflatoxins in Human Food, Docket No. FDA2021D0243 for Compliance Policy Guide Sec. 570.200
Aflatoxins in Brazil Nuts, Docket No.
FDA2021D0244 for Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut Products, and Docket No. FDA2021D0245 for Compliance Policy Guide Sec. 570.500
Aflatoxins in Pistachio Nuts. Received comments will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION. We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/
blacked out, will be available for public viewing and posted on https

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www.regulations.gov. Submit both copies to the Dockets Management Staff.
If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
Submit written requests for single copies of the guidances to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
4337, Silver Spring, MD 20993. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidances.
FOR FURTHER INFORMATION CONTACT:
Mischelle Ledet, Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 2407015986.
SUPPLEMENTARY INFORMATION:
I. Background We are announcing the availability of four CPGs for FDA staff entitled Compliance Policy Guide Sec. 555.400
Aflatoxins in Human Food, Compliance Policy Guide Sec. 570.200
Aflatoxins in Brazil Nuts, Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut Products, and Compliance Policy Guide Sec. 570.500
Aflatoxins in Pistachio Nuts. We are issuing these guidances consistent with our good guidance practices regulation 21 CFR 10.115. We are issuing these four CPGs as final and without first providing an opportunity to comment
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